FDA Fast Track designation for SGLT2 inhibitor in HFrEF and HFpEF
The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of dapagliflozin to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. The Fast Track designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of dapagliflozin in patients with HFrEF and HFpEF, respectively.
In August 2019 the FDA granted Fast Track designation for the development of dapagliflozin to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease.
Dapagliflozin is an oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2DM. Dapagliflozin is being tested in a robust program of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.